Phase 3 data presented for CEDAR, SEQUOIA studies
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SAN FRANCISCO — Vision gains achieved in the first year of the CEDAR and SEQUOIA studies were maintained in the second year with only four treatments of abicipar intravitreal injections, comparable to results achievable with monthly ranibizumab treatment, according to a speaker.
“The improvements in visual acuity and retinal thickness were maintained through week 104 and were similar for abicipar every 12 weeks vs. ranibizumab every 4 weeks: 10 injections over 2 years vs. 25 injections,” Rahul N. Khurana, MD, said at Retina Subspecialty Day at the American Academy of Ophthalmology annual meeting.
Previously, the two studies met prespecified primary endpoints of the proportion of patients with stable vision at week 52, demonstrating noninferiority in both 8-week and 12-week regimens of abicipar (Allergan and Molecular Partners) compared with monthly ranibizumab (Genentech). Through week 104, patients received abicipar 2 mg every 8 weeks or every 12 weeks, or ranibizumab 0.5 mg every 4 weeks.
From baseline to week 52, patients in the 8-week group gained 8.9 letters of visual acuity, the 12-week group gained 7.4 letters, and the ranibizumab group gained 9.4 letters. From week 52 to week 104, mean changes in visual acuity were similar to those in year 1, with the 8-week group gaining 7.8 letters from baseline, the 12-week group gaining 6.1 letters and the ranibizumab group gaining 8.5 letters.
At week 104, stable vision was demonstrated in 93% of patients in the abicipar 8-week group, 90% of patients in the abicipar 12-week group and 94% of patients in the ranibizumab group, according to Khurana.
Central retinal thickness also continued to decrease in year 2 compared with year 1, he noted. – by Robert Linnehan
Reference: Khurana RN. Abicipar for neovascular age-related macular degeneration: Two-year results from CEDAR and SEQUOIA phase 3. Presented at: American Academy of Ophthalmology annual meeting; October 11-15, 2019; San Francisco.
Disclosure: Khurana reports he has served as a consultant/advisor for Alkahest, Allergan, Clearside Biomedical and Regeneron. He has received grant support from Allergan, Roche, Santen and Clearside Biomedical.